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Tailored Tobacco Quitline for Rural Veterans

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01592695
First received: April 11, 2012
Last updated: June 12, 2012
Last verified: June 2012

April 11, 2012
June 12, 2012
June 2012
September 2012   (final data collection date for primary outcome measure)
Treatment satisfaction [ Time Frame: End of treatment (seven weeks after baseline) ] [ Designated as safety issue: No ]
Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.
Same as current
Complete list of historical versions of study NCT01592695 on ClinicalTrials.gov Archive Site
  • Tobacco use [ Time Frame: Six-month follow-up ] [ Designated as safety issue: No ]
    At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence) and any use of tobacco following an initial two-week grace period following the planned quit date (prolonged abstinence).
  • Alcohol use [ Time Frame: Six-month follow-up ] [ Designated as safety issue: No ]
    Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module. Based on this information, several metrics of alcohol consumption will be obtained including: 1) average number of drinking days per week, 2) average number of drinks per drinking day, 3) number of drinks per week 4) number of heavy drinking days, and 5) maximum drinks consumed on a single occasion.
  • Depressive symptoms [ Time Frame: Six-month follow-up ] [ Designated as safety issue: No ]
    Depressive symptoms will be assessed among participants who receive the depression treatment using the Patient Health Questionnaire 9 (PHQ-9).
  • Body weight [ Time Frame: Six-month follow-up ] [ Designated as safety issue: No ]
    Change in body weight following smoking cessation will be assessed via self-report and chart review among those receiving the weight management treatment module.
  • Enrollment rate [ Time Frame: 6 months after study initiation ] [ Designated as safety issue: No ]
    The number of participants enrolled each month will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.
  • Retention [ Time Frame: End of treatment (seven weeks after baseline) ] [ Designated as safety issue: No ]
    The proportion of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.
  • Treatment attendance [ Time Frame: End of treatment (seven weeks after baseline) ] [ Designated as safety issue: No ]
    The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.
Same as current
Not Provided
Not Provided
 
Tailored Tobacco Quitline for Rural Veterans
Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity

The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are:

  1. Study the feasibility of an individually-tailored telephone intervention for rural smokers.
  2. Examine the impact of the intervention on tobacco use outcomes.
  3. Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.

Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers.

Smokers frequently experience conditions and concerns that adversely impact their ability to quit smoking. Depression and risky alcohol use, both of which are prevalent among smokers, reduce the likelihood of successfully quitting smoking. Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting. Therefore, in order to be most effective, tobacco cessation interventions will need to address these important issues. Presently, treatment for nicotine dependence, risky alcohol use, depression, and weight management is typically delivered separately and without optimal integration among providers, an approach which only serves to fragment care and increase the number of required visits, further reduce rural smokers' access to care.

In an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs. Results will provide valuable information regarding the potential to more widely implement an individually-tailored telephone intervention for rural smokers.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cigarette Smoking
  • Drug: Nicotine replacement therapy - transdermal nicotine patch
    Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
  • Behavioral: Tailored behavioral intervention
    Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.
  • Behavioral: Tobacco quitline referral
    Participants assigned to this condition will receive a referral to their state tobacco quitline. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.
  • Drug: Nicotine replacement therapy - nicotine gum
    Medication selection will be determined based on individual participant preferences, medical history, and contraindications
  • Drug: Nicotine replacement therapy - nicotine lozenge
    Medication selection will be determined based on individual participant preferences, medical history, and contraindications
  • Drug: Bupropion SR
    Medication selection will be determined based on individual participant preferences, medical history, and contraindications
    Other Name: Zyban
  • Drug: Varenicline
    Medication selection will be determined based on individual participant preferences, medical history, and contraindications
    Other Name: Chantix
  • Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum
    Medication selection will be determined based on individual participant preferences, medical history, and contraindications
  • Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge
    Medication selection will be determined based on individual participant preferences, medical history, and contraindications
  • Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion
    Medication selection will be determined based on individual participant preferences, medical history, and contraindications
  • Behavioral: Alcohol use risk reduction
    Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
    Other Names:
    • Risky alcohol use
    • Harm reduction
  • Behavioral: Behavioral activation for the treatment of depression
    Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
    Other Name: Depression
  • Behavioral: Behavioral management of post-cessation weight gain
    Participants with concerns about gaining weight after quitting smoking may receive this six-session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.
    Other Name: Weight management
  • Experimental: Tailored Intervention Group
    Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues associated with cigarette smoking.
    Interventions:
    • Drug: Nicotine replacement therapy - transdermal nicotine patch
    • Behavioral: Tailored behavioral intervention
    • Drug: Nicotine replacement therapy - nicotine gum
    • Drug: Nicotine replacement therapy - nicotine lozenge
    • Drug: Bupropion SR
    • Drug: Varenicline
    • Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum
    • Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge
    • Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion
    • Behavioral: Alcohol use risk reduction
    • Behavioral: Behavioral activation for the treatment of depression
    • Behavioral: Behavioral management of post-cessation weight gain
  • Active Comparator: Enhanced Standard of Care Group
    Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
    Interventions:
    • Drug: Nicotine replacement therapy - transdermal nicotine patch
    • Behavioral: Tobacco quitline referral
    • Drug: Nicotine replacement therapy - nicotine gum
    • Drug: Nicotine replacement therapy - nicotine lozenge
    • Drug: Bupropion SR
    • Drug: Varenicline
    • Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum
    • Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge
    • Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
March 2013
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Being a veteran
  • 18 + years of age
  • Smoke cigarettes on at least a daily basis
  • Receive primary care from the Iowa City VAMC or Coralville Clinic
  • Live in a non-metropolitan area (based on RUCA codes)
  • Be willing to make a quit attempt in the next 30 days
  • Be capable of providing informed consent
  • Have access to a telephone (land line or cell phone)
  • Have a stable residence

Exclusion Criteria:

  • Planning to move within the next 12 months
  • Presence of a terminal illness
  • Pregnancy
  • Unstable psychiatric disorder (e.g., acute psychosis)
  • Currently pregnant
  • Incarcerated
  • Institutionalized
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01592695
N32-FY12Q1-S1-P00005
No
University of Iowa
University of Iowa
Department of Veterans Affairs
Principal Investigator: Mark VanderWeg, PhD VRHRC-CR
University of Iowa
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP